Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.
FDA Recall Z-1336-04 · Posted 2004-08-11
Recalling FirmFisher Diagnostic, A Company of Fisher Scientific LLC
Recall StatusTerminated
Product CodeGHH
Date Initiated2004-07-01
Date Terminated2004-12-07
Product Quantity5677 kits
Reason for Recall
Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
Firm Action
The recalling firm notified consignees on 7/1/04 by letter flagged as a customer notification. The notice describes the potential for invalid control results using the speckled cards. The letter requests users to return the cards for replacement. Defective cards are described as isolated to those packaged in heat sealed cellophane type bags. The firm requests customers to return a response form with quantity needed for replacement.
Root Cause
Other
Distribution Pattern
Product was sold primarily to clinical laboratories nationwide and to international distributors
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.